FDA Adverse Event
Injury
Summary report: N
AXONICS
MDR report key: 23062860
·
Received September 16, 2025
Report
- Report Number
- 2124215-2025-63791
- Event Type
- Injury
- Date Received
- September 16, 2025
- Date of Event
- August 20, 2025
- Report Date
- October 6, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.
Additional Manufacturer Narrative · 0
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR LOST A SIGNIFICANT AMOUNT OF WEIGHT WHICH ALLOWED FOR THE DEVICE TO BECOME MOVABLE IN THE POCKET. A POCKET REVISION PROCEDURE TOOK PLACE. THERE WERE NO PATIENT COMPLICATIONS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR LOST A SIGNIFICANT AMOUNT OF WEIGHT WHICH ALLOWED FOR THE DEVICE TO BECOME MOVABLE IN THE POCKET. A POCKET REVISION PROCEDURE TOOK PLACE. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287539 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T051983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention| H |